ABSTRACT

The aim of present research work is to develop and validate UV-spectrophotometric and High Performance Thin Layer Chromatography (HPTLC) methods for Eluxadoline. The estimation of Eluxadoline was performed by both UV and HPTLC method with detection wavelength of 238 nm. Chromatographic separation was carried on TLC aluminium plates pre-coated with silica gel G 60 F254 with methanol: ethyl acetate: triethylamine (5:5:0.1 v/v) as mobile phase. The retardation factor (RF) was observed to be 0.45±0.02.The developed methods were successfully validated as per ICH Q2 (R1) guideline. Methods were found to be linear within the range of 2-12µg/ml with correlation coefficient R2= 0.9963 (for UV method) and 200-1000 ng/band with correlation coefficient R2 = 0.9982 (for HPTLC method). The methods were precise as %RSD < 2 % and accurate as % recovery were found to be in range of 98-102 %. LOQ of developed methods were found to be 2.27 µg/ml and 87.98 ng/band for UV and HPTLC method respectively. The results of assay and accuracy studies of both methods were evaluated by student t test. Statistical analysis shows that there is no significant difference (p>0.05) between UV and HPTLC methods regarding accuracy and assay results. Keyword: Eluxadoline, HPTLC, Student t test, UV method
Publication date: 01/11/2022

https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6618.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.11.6618